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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 21-572/S-031
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`Food and Drug Administration
`Silver Spring MD 20993
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` SUPPLEMENT APPROVAL
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`Cubist Pharmaceuticals, Inc.
`Attention: David S. Mantus, Ph.D.
`Vice President, Regulatory Affairs
`65 Hayden Avenue
`Lexington, MA 02421
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`Dear Dr. Mantus:
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`Please refer to your Supplemental New Drug Application (sNDA) dated February 11, 2010,
`received February 12, 2010, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Cubicin (daptomycin for injection).
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`This “Changes Being Effected” supplemental new drug application provides for a revision to the
`“Post-Marketing Experience” section of the labeling text to add the adverse reaction
` Clostridium difficile-associated diarrhea under the subheading “Infections and Infestations.”
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`We have completed our review of this supplemental application and it is approved, effective on
`the date of this letter, for use as recommended the agreed-upon labeling text attached to our
`action letter to you and dated November 30, 2010.
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit, using the FDA
`automated drug registration and listing system (eLIST), the content of labeling
`[21 CFR 314.50(l)] in structured product labeling (SPL) format, as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is
`identical to the enclosed labeling (text for the package insert, text for the patient package insert,
`Medication Guide) and include the labeling changes proposed in any pending “Changes Being
`Effected” (CBE) supplements and any annual reportable changes not included in the enclosed
`labeling. Information on submitting SPL files using eLIST may be found in the guidance for
`industry titled “SPL Standard for Content of Labeling Technical Qs and As” at:
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`The SPL will be accessible from publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications for this NDA, including CBE
`supplements for which FDA has not yet issued an action letter, with the content of labeling
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`Reference ID: 2872896
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` NDA 21-572/S-031
`Page 2
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`[21 CFR 314.50(l)(1)(i)] in MS Word format that includes the changes approved in this
`supplemental application.
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`LETTERS TO HEALTH CARE PROFESSIONALS
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`If you decide to issue a letter communicating important safety-related information about this
`drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit, at least
`24 hours prior to issuing the letter, an electronic copy of the letter to this NDA to the following
`address:
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`MedWatch Program
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`Office of Special Health Issues
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`Food and Drug Administration
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`10903 New Hampshire Ave
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`Building 32, Mail Stop 5353
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`Silver Spring, MD 20993
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call J. Christopher Davi, MS, Senior Regulatory Project Manager, at
`(301) 796-0702.
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`Sincerely,
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`{See appended electronic signature page}
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`Katherine A. Laessig, MD
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`Deputy Director
`Division of Anti-Infective and Ophthalmology Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
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`Reference ID: 2872896
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`KATHERINE A LAESSIG
`12/06/2010
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`Reference ID: 2872896
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